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Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00193999
First received: September 15, 2005
Last updated: October 26, 2009
Last verified: September 2008
History of Changes
  Purpose

Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG) tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are routinely used in patients undergoing surgery. They are presumed to reduce postoperative nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric volumes; however, their insertion and use is not however without potentially serious complications. Existing literature does not address their efficacy in reducing PONV after cardiac surgery. However, current evidence suggests that up to 50% of patients in this group suffer significant nausea and vomiting. The objective of this study is to determine whether NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.


Condition Intervention Phase
Heart Disease
 Device: Placement of nasogastric tube
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting. A Prospective Randomized Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Primary outcome measures will be the incidence and severity of postoperative nausea and vomiting as well as paint while the patient is in the CVICU

Estimated Enrollment: 300
Study Start Date: February 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing coronary artery bypass graft and/or valvular surgery,
  • age 18-80 year olds
  • signed informed consent
  • elective or urgent surgery

Exclusion Criteria:

  • past history of oesophageal surgery, oesophageal varices or stricture,
  • patients who have received antiemetic medication in the 24 hours before surgery
  • emergency surgery
  • patients that require re-sternotomy, or are not extubated 24 hours after admission to the intensive care unit, will be excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193999

Locations
Canada, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: George Djaiani, MD Toronto General Hospital, University Health Network
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George Djaiani, Toronto General Hospital, University Health Network
ClinicalTrials.gov Identifier: NCT00193999     History of Changes
Other Study ID Numbers: UHN REB 02-0601-B
Study First Received: September 15, 2005
Last Updated: October 26, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Nasogastric Tubes
Nausea
Vomiting
Cardiac surgery

Additional relevant MeSH terms:
Heart Diseases
Nausea
Vomiting
 Cardiovascular Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013